A Randomized, Two-Period, Two-Sequence, Crossover Bioequivalence Study of Bupropion Hydrochloride Sustained-Release Tablets in Healthy Adult Volunteers under Fed Conditions

The primary objective of this study is to evaluate the bioequivalence of bupropion hydrochloride 150 mg sustained-release tablets manufactured for Sun Pharmaceutical Industries Limited compared to the reference product, PrOdan Bupropion SR, in healthy adult subjects under fed conditions. Establishing bioequivalence is clinically essential to ensure that the test product provides comparable pharmacokinetic profiles to the reference medication for the treatment of major depressive disorder. 8

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers within the age range of 18 to 30 years. The cohort includes both male and female individuals. The population is categorized as vulnerable. Participants may have a history of major depressive disorder.

This bioequivalence study is designed as a double-blind, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover trial. The investigation compares bupropion hydrochloride sustained-release tablets 150 mg manufactured for Sun Pharmaceutical Industries Limited with PrOdan Bupropion SR in healthy adult human subjects under fed conditions. The research methodology aims to assess the equivalence of the two products. Participants will undergo a sequence of study visits, beginning with a screening visit to determine eligibility. Following the administration of the study medication, subjects will attend necessary follow-up visits to monitor physiological parameters and pharmacokinetic profiles. The clinical process concludes with an end-of-study visit. Early termination from the study may occur based on predefined clinical criteria or safety protocols. The total duration of the trial is estimated to span from October 2025 to May 2026.

The assessment of efficacy in this phase 2 clinical trial focuses on the therapeutic impact on major depressive disorder. The evaluation of clinical outcomes will be conducted through standardized methodology to determine the response to the investigational intervention.